SEC Form 10-Q filed by Entera Bio Ltd.

Oxyntomodulin is a naturally occurring peptide hormone found in the colon, with glucagon-like-peptide 1 (GLP-1) and glucagon dual agonist activity that suppresses appetite and induces weight loss. OPKO has developed several proprietary, modified OXM analogs as potential candidates for treating obesity, including an injectable pegylated peptide which demonstrated safety in over 430 subjects and significant reductions in weight loss and decreased plasma triglyceride levels in over 100 subjects in completed phase 2/2B studies.

In October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas also launched extensive rocket attacks on the Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in over 1,200 deaths and thousands of injuries. Hamas additionally abducted and took hostage over 250  Israeli and non-Israeli civilians and soldiers into Gaza, including infants, children, and young and elderly women and men of all religious faiths. Following the attack, Israel’s security cabinet commenced a counter-offense military campaign against Hamas. The intensity and duration of Israel’s current war against Hamas is difficult to predict, as are such war’s economic implications on the Israel's economy in general.

In addition, since April 2024, Israel has experienced direct attacks from Iran, involving hundreds of drones and ballistic missiles launched directly towards highly populated civilian areas across the North, South and Center of Israel, including military bases. The Israeli defense systems, aided by international allies, successfully intercepted the majority of these attacks, minimizing physical damage and casualties. Additionally, since October 8,  2023, Hezbollah has launched thousands of guided missiles to the North of Israel causing the displacement of over 95,000 Israelis from their homes; and the Houthis, a military organization based in Yemen, have launched a series of attacks on global shipping routes in the Red Sea, as well as direct attacks on various parts of Israel. Such incidents contribute to regional instability and could potentially escalate into broader conflicts with Iran and its proxies in the Middle East, affecting Israel's political and trade relations, especially with neighboring countries and global allies. The situation remains fluid, and the potential for further escalation exists.

While we have a few employees who have been called to active military service, the ongoing war with Hamas, Hezbollah,  Iran and its proxies have not, to date, materially impacted our business or operations. Furthermore, we do not expect any delays to any of our programs as a result of such conflicts. While early-stage R&D personnel and management are located in Israel, other core activities including clinical, regulatory and our supply chain are not. However, we cannot currently predict the intensity or duration of Israel’s defensive military measures against Hamas, Hezbollah and Iran,  nor can we predict how such conflicts will ultimately affect our business and operations or Israel’s economy in general.

Since our inception, we have raised a total of $93.1 million from a combination of public and private equity offerings, IIA grants and the issuance of Ordinary Shares upon the exercise of options and warrants. Since inception, we have incurred significant losses. For the three months ended September 30, 2024 and 2023, our operating losses were $3.0 million and $2.4 million, respectively. For the nine months ended September 30, 2024 and 2023, our operating losses were $7.2 million and $6.9 million, respectively, and we expect to continue to incur significant expenses and losses for the foreseeable future.

As of September 30, 2024, we had an accumulated deficit of $111.6 million. Our losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of our clinical trials, our expenditures on research and development activities and any third-party collaborations into which we may enter.

The Company is engaged in research and development activities, and it has not derived significant income from its activities and has incurred an accumulated deficit and negative cash flows from operating activities since inception. These factors raise substantial doubt as to the Company's ability to continue as a going concern. The unaudited condensed consolidated financial statements included herein have been prepared assuming that we will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. See Part I, Item 1A-Risk Factors—Risks Related to Our Financial Position and Need for Additional Capital contained in our 2023 Annual Report.

As of September 30, 2024, we had cash and cash equivalents of $6.9 million. We believe that our existing cash resources will be sufficient to meet our projected operating requirements into the third quarter of 2025, which include the capital required to fund our ongoing operations, including regulatory expenses and optimization related to the preparation for the planned EB613 phase 3 study, research and development, the completion of an additional Phase 1 PK study related to our new generation platform and the GLP-2/OXM collaborative research we are conducting with OPKO. Our ability to commence the Phase 3 study of EB613 in osteoporosis will depend on finalizing discussions with the FDA in connection with their anticipated qualification of the total hip BMD endpoint and will require additional funding, which may not be available on reasonable terms, or at all. Any delay or our inability to secure such funding will delay or prevent the commencement of these studies.

In order to fund further operations, we will need to raise additional capital. We may raise these funds through a variety of means, including private or public equity offerings, debt financings and strategic collaborations. Additional financing may not be available when we need it or may not be available on terms that are favorable to us.

As of September 30, 2024, we had a total of 20 employees, of whom 18 are full-time employees, and all are based in Israel. In addition, we employ a number of specialized Clinical, Non-Clinical, Regulatory, and Development advisors based in the United States, the United Kingdom and Europe. Our operations are located in Jerusalem, Israel.